This is a single-center, prospective, randomized, controlled, and double-blind clinical study designed to evaluate the clinical outcomes of the minimally invasive Le Fort I osteotomy (MI-Le Fort I) compared with the conventional Le Fort I osteotomy (Le Fort I) in patients undergoing orthognathic surgery. Patients aged 18 to 40 years, classified as ASA I, will be randomly assigned to one of two groups: the MI-Le Fort I group or the Le Fort I group. Intraoperative parameters including blood loss (mL) and operative time (minutes) will be recorded. Postoperative facial swelling will be assessed using three-dimensional stereophotogrammetry, pain intensity will be measured with a visual analog scale (VAS). Additional outcomes will include hospitalization time, early recovery of upper lip sensation assessed by the pinprick test, and pterygomaxillary separation patterns evaluated using postoperative CBCT imaging. The aim of this study is to compare the clinical outcomes of the MI-Le Fort I approach with the Le Fort I approach under controlled conditions. The study hypothesizes that the MI-Le Fort I osteotomy improves patient outcomes by minimizing soft tissue trauma without compromising surgical effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
47
Patients in this arm undergo the minimally invasive Le Fort I osteotomy (MI-Le Fort I). The procedure involves limited mucosal incision and soft tissue dissection. The pterygomaxillary separation is achieved through a frontal approach without osteotomizing the pterygoid plates. This technique aims to reduce surgical morbidity, intraoperative bleeding, and postoperative swelling compared to the conventional Le Fort I osteotomy.
Patients in this arm undergo the conventional Le Fort I osteotomy technique. The procedure includes standard wide mucoperiosteal flap elevation and lateral maxillary wall exposure, followed by pterygomaxillary separation using a curved osteotome and mallet. This approach serves as the control group for comparison with the minimally invasive technique.
Erciyes University Faculty of Dentistry Department of Oral and Maxillofacial Surgery
Kayseri, Turkey (Türkiye)
Operative Time
Operative time will be measured in minutes, from the initial mucosal incision to the final suture placement, using a chronometer.
Time frame: Intraoperative period (from mucosal incision to final suture placement)
Bleeding
Bleeding volume will be measured in milliliters from the initial mucosal incision to the final suture placement, using a calibrated aspirator.
Time frame: Intraoperative period (from mucosal incision to final suture placement)
Postoperative Edema
The 3dMD imaging system (3dMD, Atlanta, GA, USA) and 3dMD Vultus software were used to evaluate the amount of postoperative edema. Three-dimensional images were taken with the teeth in maximum intercuspation, lips relaxed, and eyes open on postoperative days 1, 7, 14, 30, and 90. Edema was calculated separately for the right and left sides and was recorded as surface area in square centimeters (cm²).
Time frame: Postoperative days 1, 7, 14, 30 and 90
Postoperative Pain
Postoperative pain was evaluated using the Visual Analogue Scale for the right and left sides separately. In this scale, '0' meant no pain, and '100' represented maximum pain. Patients were questioned at postoperative 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th and 12th hours, and the results were recorded in the patient follow-up form.
Time frame: Postoperative hours 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Hospitalization
The total postoperative hospitalization time (in hours) will be recorded for each participant. The measurement will cover the period from the end of surgery until hospital discharge.
Time frame: From the end of surgery until hospital discharge (typically within 48 hours)
Pterygomaxillary Separation Pattern
The pterygomaxillary separation pattern will be evaluated using postoperative cone-beam computed tomography (CBCT) images. Each side will be classified according to the type of separation between the maxillary tuberosity and the pterygoid plates. The assessment aims to compare the frequency and characteristics of separation types between the minimally invasive Le Fort I osteotomy and the conventional Le Fort I osteotomy groups.
Time frame: Postoperative first day
Neurosensory Test: Upper Lip Sensation Recovery
Recovery of upper lip sensation will be evaluated using the pinprick test applied bilaterally in the upper lip region. Each side will be scored on a five-point ordinal scale to determine the degree of infraorbital nerve recovery.
Time frame: Postoperative days 7, 14, and 30
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